clinical-trial
type: StructureDefinition
node role: treeRoot
id:
  v: clinical-trial
text:
  status:
    v: extensions
  div: Generated Narrative: StructureDefinition clinical-trial Nom Drapeaux Card. Type Description et contraintes<img src="[binary]" alt="doco" style="background-color: inherit"/> ResearchStudy 0..* ResearchStudy Investigation to increase healthcare-related patient-independent knowledge identifier 1..1 Identifier EudraCT number of the clinical trial title S 1..1 string Clinical trial name <img src="[binary]" alt="doco" style="background-color: inherit"/> Documentation for this format
url:
  v: https://ig-osiris.cancer.fr/ig/osiris/StructureDefinition/clinical-trial
version:
  v: 1.1.0
name:
  v: ClinicalTrial
title:
  v: Oncology Clinical Trial
status:
  v: draft
date:
  v: 2025-04-03T14:14:07+02:00
publisher:
  v: institutcancer
contact:
  name:
    v: institutcancer
  telecom:
    system:
      v: url
    value:
      v: http://cancer.fr
  telecom:
    system:
      v: email
contact:
  name:
    v: Aurélien JOBARD
  telecom:
    system:
      v: email
description:
  v: Oncology clinical trial used to associate a Onco Patient to a Clinical Trial
fhir version:
  v: 4.0.1
mapping:
  identity:
    v: fhir-osiris-study
  uri:
    v: Study
  name:
    v: Fhir-osiris to osiris
mapping:
  identity:
    v: BRIDG5.1
  uri:
    v: https://bridgmodel.nci.nih.gov
  name:
    v: BRIDG 5.1 Mapping
mapping:
  identity:
    v: v2
  uri:
    v: http://hl7.org/v2
  name:
    v: HL7 v2 Mapping
mapping:
  identity:
    v: rim
  uri:
    v: http://hl7.org/v3
  name:
    v: RIM Mapping
mapping:
  identity:
    v: clinicaltrials-gov
  uri:
    v: http://clinicaltrials.gov
  name:
    v: ClinicalTrials.gov Mapping
mapping:
  identity:
    v: w5
  uri:
    v: http://hl7.org/fhir/fivews
  name:
    v: FiveWs Pattern Mapping
kind:
  v: resource
abstract:
  v: false
type:
  v: ResearchStudy
base definition:
  v: http://hl7.org/fhir/StructureDefinition/ResearchStudy
  link: http://hl7.org/fhir/StructureDefinition/ResearchStudy
derivation:
  v: constraint
snapshot:
  extension:
    url:
      v: http://hl7.org/fhir/tools/StructureDefinition/snapshot-base-version
    value: string
      v: 4.0.1
  element:
    id:
      v: ResearchStudy
    path:
      v: ResearchStudy
    short:
      v: Investigation to increase healthcare-related patient-independent knowledge
    definition:
      v: A process where a researcher or organization plans and then executes a series of steps intended to increase the field of healthcare-related knowledge. This includes studies of safety, efficacy, comparative effectiveness and other information about medications, devices, therapies and other interventional and investigative techniques. A ResearchStudy involves the gathering of information about human or animal subjects.
    comment:
      v: Need to make sure we encompass public health studies.
    alias:
      v: Clinical Trial
    alias:
      v: Study
    min:
      v: 0
    max:
      v: *
    base:
      path:
        v: ResearchStudy
      min:
        v: 0
      max:
        v: *
    constraint:
      key:
        v: dom-2
      severity:
        v: error
      human:
        v: If the resource is contained in another resource, it SHALL NOT contain nested Resources
      expression:
        v: contained.contained.empty()
      xpath:
        v: not(parent::f:contained and f:contained)
      source:
        v: http://hl7.org/fhir/StructureDefinition/DomainResource
        link: http://hl7.org/fhir/StructureDefinition/DomainResource
    constraint:
      key:
        v: dom-3
      severity:
        v: error
      human:
        v: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource
      expression:
        v: contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
      xpath:
        v: not(exists(for $id in f:contained/*/f:id/@value return $contained[not(parent::*/descendant::f:reference/@value=concat('#', $contained/*/id/@value) or descendant::f:reference[@value='#'])]))
      source:
        v: http://hl7.org/fhir/StructureDefinition/DomainResource
        link: http://hl7.org/fhir/StructureDefinition/DomainResource
    constraint:
      key:
        v: dom-4
      severity:
        v: error
      human:
        v: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated
      expression:
        v: contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
      xpath:
        v: not(exists(f:contained/*/f:meta/f:versionId)) and not(exists(f:contained/*/f:meta/f:lastUpdated))
      source:
        v: http://hl7.org/fhir/StructureDefinition/DomainResource
        link: http://hl7.org/fhir/StructureDefinition/DomainResource
    constraint:
      key:
        v: dom-5
      severity:
        v: error
      human:
        v: If a resource is contained in another resource, it SHALL NOT have a security label
      expression:
        v: contained.meta.security.empty()
      xpath:
        v: not(exists(f:contained/*/f:meta/f:security))
      source:
        v: http://hl7.org/fhir/StructureDefinition/DomainResource
        link: http://hl7.org/fhir/StructureDefinition/DomainResource
    constraint:
      extension:
        value: boolean
      extension:
        value: markdown
      key:
        v: dom-6
      severity:
        v: warning
      human:
        v: A resource should have narrative for robust management
      expression:
        v: text.`div`.exists()
      xpath:
        v: exists(f:text/h:div)
      source:
        v: http://hl7.org/fhir/StructureDefinition/DomainResource
        link: http://hl7.org/fhir/StructureDefinition/DomainResource

boolean
v: true

markdown
v: When a resource has no narrative, only systems that fully understand the data can display the resource to a human safely. Including a human readable representation in the resource makes for a much more robust eco-system and cheaper handling of resources by intermediary systems. Some ecosystems restrict distribution of resources to only those systems that do fully understand the resources, and as a consequence implementers may believe that the narrative is superfluous. However experience shows that such eco-systems often open up to new participants over time.

v: false

v: false

identity:
  v: fhir-osiris-study
map:
  v: Study
comment:
  v: Mapping from FHIR-osiris Study to osiris Study

identity:
  v: rim
map:
  v: Entity. Role, or Act

identity:
  v: BRIDG5.1
map:
  v: ObservationalStudyProtocolVersion; Study; StudyProtocolVersion

identity:
  v: v2
map:
  v: OBX

identity:
  v: rim
map:
  v: Observation[classCode=CLNTRL, moodCode=EVN]

id:
  v: ResearchStudy.id
path:
  v: ResearchStudy.id
short:
  v: Logical id of this artifact
definition:
  v: The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.
comment:
  v: The only time that a resource does not have an id is when it is being submitted to the server using a create operation.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Resource.id
  min:
    v: 0
  max:
    v: 1
type:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type
    value: url
      v: id
  code:
    v: http://hl7.org/fhirpath/System.String
is modifier:
  v: false
is summary:
  v: true

id:
  v: ResearchStudy.meta
path:
  v: ResearchStudy.meta
short:
  v: Metadata about the resource
definition:
  v: The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Resource.meta
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: Meta
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
is modifier:
  v: false
is summary:
  v: true

id:
  v: ResearchStudy.implicitRules
path:
  v: ResearchStudy.implicitRules
short:
  v: A set of rules under which this content was created
definition:
  v: A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.
comment:
  v: Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of it's narrative along with other profiles, value sets, etc.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Resource.implicitRules
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: uri
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
is modifier:
  v: true
is modifier reason:
  v: This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation
is summary:
  v: true

id:
  v: ResearchStudy.language
path:
  v: ResearchStudy.language
short:
  v: Language of the resource content
definition:
  v: The base language in which the resource is written.
comment:
  v: Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute).
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Resource.language
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: code
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
is modifier:
  v: false
is summary:
  v: false
binding:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/elementdefinition-maxValueSet
    value: canonical
      v: http://hl7.org/fhir/ValueSet/all-languages
      link: http://hl7.org/fhir/ValueSet/all-languages
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName
    value: string
      v: Language
  strength:
    v: preferred
  description:
    v: A human language.
  value set:
    v: http://hl7.org/fhir/ValueSet/languages
    link: http://hl7.org/fhir/ValueSet/languages

id:
  v: ResearchStudy.text
path:
  v: ResearchStudy.text
short:
  v: Text summary of the resource, for human interpretation
definition:
  v: A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety.
comment:
  v: Contained resources do not have narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a "text blob" or where text is additionally entered raw or narrated and encoded information is added later.
alias:
  v: narrative
alias:
  v: html
alias:
  v: xhtml
alias:
  v: display
min:
  v: 0
max:
  v: 1
base:
  path:
    v: DomainResource.text
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: Narrative
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: Act.text?

id:
  v: ResearchStudy.contained
path:
  v: ResearchStudy.contained
short:
  v: Contained, inline Resources
definition:
  v: These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, and nor can they have their own independent transaction scope.
comment:
  v: This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags In their meta elements, but SHALL NOT have security labels.
alias:
  v: inline resources
alias:
  v: anonymous resources
alias:
  v: contained resources
min:
  v: 0
max:
  v: *
base:
  path:
    v: DomainResource.contained
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Resource
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: N/A

id:
  v: ResearchStudy.extension
path:
  v: ResearchStudy.extension
short:
  v: Additional content defined by implementations
definition:
  v: May be used to represent additional information that is not part of the basic definition of the resource. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
alias:
  v: extensions
alias:
  v: user content
min:
  v: 0
max:
  v: *
base:
  path:
    v: DomainResource.extension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  xpath:
    v: exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    link: http://hl7.org/fhir/StructureDefinition/Extension
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: N/A

id:
  v: ResearchStudy.modifierExtension
path:
  v: ResearchStudy.modifierExtension
short:
  v: Extensions that cannot be ignored
definition:
  v: May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
requirements:
  v: Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension).
alias:
  v: extensions
alias:
  v: user content
min:
  v: 0
max:
  v: *
base:
  path:
    v: DomainResource.modifierExtension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  xpath:
    v: exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    link: http://hl7.org/fhir/StructureDefinition/Extension
is modifier:
  v: true
is modifier reason:
  v: Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: N/A

id:
  v: ResearchStudy.identifier
path:
  v: ResearchStudy.identifier
short:
  v: EudraCT number of the clinical trial
definition:
  v: The number in the EudraCT clinical trials database.
requirements:
  v: Allows identification of the research study as it is known by various participating systems and in a way that remains consistent across servers.
min:
  v: 1
max:
  v: 1
base:
  path:
    v: ResearchStudy.identifier
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Identifier
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: fhir-osiris-study
  map:
    v: OSIRIS_pivot_Treatment.Treatment_ClinicalTrialId
mapping:
  identity:
    v: clinicaltrials-gov
  map:
    v: Organization's Unique Protocol ID; Secondary IDs
mapping:
  identity:
    v: w5
  map:
    v: FiveWs.identifier
mapping:
  identity:
    v: BRIDG5.1
  map:
    v: No BRIDG mapping (although there is DocumentVersion.identifier > StudyProtocolDocumentVersion, this is arguably a different semantic)
mapping:
  identity:
    v: rim
  map:
    v: .identifier

id:
  v: ResearchStudy.title
path:
  v: ResearchStudy.title
short:
  v: Clinical trial name
definition:
  v: If the treatment is part of a clinical trial, its name is indicated.
min:
  v: 1
max:
  v: 1
base:
  path:
    v: ResearchStudy.title
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: string
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: true
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: fhir-osiris-study
  map:
    v: OSIRIS_pivot_Treatment.Treatment_ClinicalTrialName
mapping:
  identity:
    v: clinicaltrials-gov
  map:
    v: Brief Title
mapping:
  identity:
    v: BRIDG5.1
  map:
    v: No BRIDG mapping (although there is StudyProtocolDocumentVersionPublicTitle this is arguably a different semantic: title of a document vs title of a research study)

id:
  v: ResearchStudy.protocol
path:
  v: ResearchStudy.protocol
short:
  v: Steps followed in executing study
definition:
  v: The set of steps expected to be performed as part of the execution of the study.
min:
  v: 0
max:
  v: *
base:
  path:
    v: ResearchStudy.protocol
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Reference
  target profile:
    v: http://hl7.org/fhir/StructureDefinition/PlanDefinition
    link: http://hl7.org/fhir/StructureDefinition/PlanDefinition
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: clinicaltrials-gov
  map:
    v: Interventions; Arm/Intervention Cross-Reference
mapping:
  identity:
    v: BRIDG5.1
  map:
    v: StudyProtocolDocumentVersionPublicTitle.name
mapping:
  identity:
    v: rim
  map:
    v: .outboundRelationship[typeCode=DEFN].target

id:
  v: ResearchStudy.partOf
path:
  v: ResearchStudy.partOf
short:
  v: Part of larger study
definition:
  v: A larger research study of which this particular study is a component or step.
requirements:
  v: Allows breaking a study into components (e.g. by study site) each with their own PI, status, enrollment, etc.
alias:
  v: container
min:
  v: 0
max:
  v: *
base:
  path:
    v: ResearchStudy.partOf
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Reference
  target profile:
    v: http://hl7.org/fhir/StructureDefinition/ResearchStudy
    link: http://hl7.org/fhir/StructureDefinition/ResearchStudy
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: BRIDG5.1
  map:
    v: CompanionStudyRelationship
mapping:
  identity:
    v: rim
  map:
    v: .inboundRelationship[typeCode=COMP].source[moodCode=EVN]

id:
  v: ResearchStudy.status
path:
  v: ResearchStudy.status
short:
  v: active | administratively-completed | approved | closed-to-accrual | closed-to-accrual-and-intervention | completed | disapproved | in-review | temporarily-closed-to-accrual | temporarily-closed-to-accrual-and-intervention | withdrawn
definition:
  v: The current state of the study.
min:
  v: 1
max:
  v: 1
base:
  path:
    v: ResearchStudy.status
  min:
    v: 1
  max:
    v: 1
type:
  code:
    v: code
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
is modifier:
  v: true
is modifier reason:
  v: This element is labeled as a modifier because it is a status element that contains status entered-in-error which means that the resource should not be treated as valid
is summary:
  v: true
binding:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName
    value: string
      v: ResearchStudyStatus
  strength:
    v: required
  description:
    v: Codes that convey the current status of the research study.
  value set:
    v: http://hl7.org/fhir/ValueSet/research-study-status|4.0.1
    link: 4.0
    link: .1
mapping:
  identity:
    v: w5
  map:
    v: FiveWs.status
mapping:
  identity:
    v: BRIDG5.1
  map:
    v: StudyOverallStatus.code
mapping:
  identity:
    v: rim
  map:
    v: .status

id:
  v: ResearchStudy.primaryPurposeType
path:
  v: ResearchStudy.primaryPurposeType
short:
  v: treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility
definition:
  v: The type of study based upon the intent of the study's activities. A classification of the intent of the study.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: ResearchStudy.primaryPurposeType
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: CodeableConcept
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
is modifier:
  v: false
is summary:
  v: true
binding:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName
    value: string
      v: ResearchStudyPrimaryPurposeType
  strength:
    v: extensible
  description:
    v: Codes for the main intent of the study.
  value set:
    v: http://hl7.org/fhir/ValueSet/research-study-prim-purp-type
    link: http://hl7.org/fhir/ValueSet/research-study-prim-purp-type
mapping:
  identity:
    v: BRIDG5.1
  map:
    v: StudyProtocolVersion.primaryPurposeTypeCode

id:
  v: ResearchStudy.phase
path:
  v: ResearchStudy.phase
short:
  v: n-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4
definition:
  v: The stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: ResearchStudy.phase
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: CodeableConcept
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
is modifier:
  v: false
is summary:
  v: true
binding:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName
    value: string
      v: ResearchStudyPhase
  strength:
    v: example
  description:
    v: Codes for the stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation.
  value set:
    v: http://hl7.org/fhir/ValueSet/research-study-phase
    link: http://hl7.org/fhir/ValueSet/research-study-phase
mapping:
  identity:
    v: clinicaltrials-gov
  map:
    v: Study Phase
mapping:
  identity:
    v: BRIDG5.1
  map:
    v: StudyProtocolVersion.phaseCode

id:
  v: ResearchStudy.category
path:
  v: ResearchStudy.category
short:
  v: Classifications for the study
definition:
  v: Codes categorizing the type of study such as investigational vs. observational, type of blinding, type of randomization, safety vs. efficacy, etc.
min:
  v: 0
max:
  v: *
base:
  path:
    v: ResearchStudy.category
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: CodeableConcept
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
is modifier:
  v: false
is summary:
  v: true
binding:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName
    value: string
      v: ResearchStudyCategory
  strength:
    v: example
  description:
    v: Codes that describe the type of research study. E.g. Study phase, Interventional/Observational, blinding type, etc.
mapping:
  identity:
    v: clinicaltrials-gov
  map:
    v: Study Type; Primary Purpose; Interventional Model; Masking; Allocation; study Classification; Observational Study Model; Time Perspective; Biospecimen Retention
mapping:
  identity:
    v: BRIDG5.1
  map:
    v: InterventionalStudyProtocolVersion; InterventionalStudyProtocol.allocationCode; InterventionalStudyProtocol.blindedRoleCode; InterventionalStudyProtocol.blindingSchemaCode; InterventionalStudyProtocol.controlTypeCode

id:
  v: ResearchStudy.focus
path:
  v: ResearchStudy.focus
short:
  v: Drugs, devices, etc. under study
definition:
  v: The medication(s), food(s), therapy(ies), device(s) or other concerns or interventions that the study is seeking to gain more information about.
min:
  v: 0
max:
  v: *
base:
  path:
    v: ResearchStudy.focus
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: CodeableConcept
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
is modifier:
  v: false
is summary:
  v: true
binding:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName
    value: string
      v: ResearchStudyFocus
  strength:
    v: example
  description:
    v: Codes for medications, devices and other interventions.
mapping:
  identity:
    v: clinicaltrials-gov
  map:
    v: Focus of Study
mapping:
  identity:
    v: w5
  map:
    v: FiveWs.what[x]
mapping:
  identity:
    v: BRIDG5.1
  map:
    v: InterventionalStudyProtocol.interventionTypeCode

id:
  v: ResearchStudy.condition
path:
  v: ResearchStudy.condition
short:
  v: Condition being studied
definition:
  v: The condition that is the focus of the study. For example, In a study to examine risk factors for Lupus, might have as an inclusion criterion "healthy volunteer", but the target condition code would be a Lupus SNOMED code.
min:
  v: 0
max:
  v: *
base:
  path:
    v: ResearchStudy.condition
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: CodeableConcept
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
is modifier:
  v: false
is summary:
  v: true
binding:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName
    value: string
      v: ConditionCode
  strength:
    v: example
  description:
    v: Identification of the condition or diagnosis.
  value set:
    v: http://hl7.org/fhir/ValueSet/condition-code
    link: http://hl7.org/fhir/ValueSet/condition-code
mapping:
  identity:
    v: clinicaltrials-gov
  map:
    v: Conditions
mapping:
  identity:
    v: w5
  map:
    v: FiveWs.what[x]
mapping:
  identity:
    v: BRIDG5.1
  map:
    v: StudyCondition.code

id:
  v: ResearchStudy.contact
path:
  v: ResearchStudy.contact
short:
  v: Contact details for the study
definition:
  v: Contact details to assist a user in learning more about or engaging with the study.
min:
  v: 0
max:
  v: *
base:
  path:
    v: ResearchStudy.contact
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: ContactDetail
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: clinicaltrials-gov
  map:
    v: Central Contact; Central Contact Backup; Overall Study Officials; Facility Contact & Backup (if Study tied to only one location); Investigators
mapping:
  identity:
    v: BRIDG5.1
  map:
    v: PointOfContact > Project > Research Project > Study > StudyProtocol > StudyProtocolVersion

id:
  v: ResearchStudy.relatedArtifact
path:
  v: ResearchStudy.relatedArtifact
short:
  v: References and dependencies
definition:
  v: Citations, references and other related documents.
min:
  v: 0
max:
  v: *
base:
  path:
    v: ResearchStudy.relatedArtifact
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: RelatedArtifact
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: clinicaltrials-gov
  map:
    v: Citations, Links, Available Study Data/Documents
mapping:
  identity:
    v: BRIDG5.1
  map:
    v: StudyProtocolDocument, StudyProtocolDocumentVersion

id:
  v: ResearchStudy.keyword
path:
  v: ResearchStudy.keyword
short:
  v: Used to search for the study
definition:
  v: Key terms to aid in searching for or filtering the study.
min:
  v: 0
max:
  v: *
base:
  path:
    v: ResearchStudy.keyword
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: CodeableConcept
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
is modifier:
  v: false
is summary:
  v: true
binding:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName
    value: string
      v: ResearchStudyKeyword
  strength:
    v: example
  description:
    v: Words associated with the study that may be useful in discovery.
mapping:
  identity:
    v: clinicaltrials-gov
  map:
    v: Keywords
mapping:
  identity:
    v: BRIDG5.1
  map:
    v: DocumentVersion.keywordCode; DocumentVersion.keywordText

id:
  v: ResearchStudy.location
path:
  v: ResearchStudy.location
short:
  v: Geographic region(s) for study
definition:
  v: Indicates a country, state or other region where the study is taking place.
min:
  v: 0
max:
  v: *
base:
  path:
    v: ResearchStudy.location
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: CodeableConcept
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
is modifier:
  v: false
is summary:
  v: true
binding:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName
    value: string
      v: Jurisdiction
  strength:
    v: extensible
  description:
    v: Countries and regions within which this artifact is targeted for use.
  value set:
    v: http://hl7.org/fhir/ValueSet/jurisdiction
    link: http://hl7.org/fhir/ValueSet/jurisdiction
mapping:
  identity:
    v: BRIDG5.1
  map:
    v: StudyProtocolVersion.participatingLocationCode

id:
  v: ResearchStudy.description
path:
  v: ResearchStudy.description
short:
  v: What this is study doing
definition:
  v: A full description of how the study is being conducted.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: ResearchStudy.description
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: markdown
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: clinicaltrials-gov
  map:
    v: Detailed Description
mapping:
  identity:
    v: BRIDG5.1
  map:
    v: StudyProtocolDocumentVersion.publicDescription

id:
  v: ResearchStudy.enrollment
path:
  v: ResearchStudy.enrollment
short:
  v: Inclusion & exclusion criteria
definition:
  v: Reference to a Group that defines the criteria for and quantity of subjects participating in the study. E.g. " 200 female Europeans between the ages of 20 and 45 with early onset diabetes".
comment:
  v: The Group referenced should not generally enumerate specific subjects. Subjects will be linked to the study using the ResearchSubject resource.
alias:
  v: patient
min:
  v: 0
max:
  v: *
base:
  path:
    v: ResearchStudy.enrollment
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Reference
  target profile:
    v: http://hl7.org/fhir/StructureDefinition/Group
    link: http://hl7.org/fhir/StructureDefinition/Group
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: clinicaltrials-gov
  map:
    v: Enrollment; Number of Groups/Cohorts (= number of "enrollment" instances); Groups (Group/Cohort Label = Group.name; Group/Cohort Description = Group.description); Eligibility (Group criteria)
mapping:
  identity:
    v: w5
  map:
    v: FiveWs.subject[x]
mapping:
  identity:
    v: BRIDG5.1
  map:
    v: InterventionalStudyProtocol.interventionGroupQuantity
mapping:
  identity:
    v: rim
  map:
    v: .participation[typeCode=SBJ].role
mapping:
  identity:
    v: w5
  map:
    v: FiveWs.subject

id:
  v: ResearchStudy.period
path:
  v: ResearchStudy.period
short:
  v: When the study began and ended
definition:
  v: Identifies the start date and the expected (or actual, depending on status) end date for the study.
alias:
  v: timing
min:
  v: 0
max:
  v: 1
base:
  path:
    v: ResearchStudy.period
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: Period
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: clinicaltrials-gov
  map:
    v: Study Start Date (start); Study Completion Date (end)
mapping:
  identity:
    v: w5
  map:
    v: FiveWs.done[x]
mapping:
  identity:
    v: BRIDG5.1
  map:
    v: ProjectConduct.dateRange; StudyProtocolVersion.plannedDuration
mapping:
  identity:
    v: rim
  map:
    v: .effectiveTime

id:
  v: ResearchStudy.sponsor
path:
  v: ResearchStudy.sponsor
short:
  v: Organization that initiates and is legally responsible for the study
definition:
  v: An organization that initiates the investigation and is legally responsible for the study.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: ResearchStudy.sponsor
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: Reference
  target profile:
    v: http://hl7.org/fhir/StructureDefinition/Organization
    link: http://hl7.org/fhir/StructureDefinition/Organization
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: clinicaltrials-gov
  map:
    v: Sponsor
mapping:
  identity:
    v: w5
  map:
    v: FiveWs.actor
mapping:
  identity:
    v: BRIDG5.1
  map:
    v: RegulatoryApplicationSponsor; StudyLegalSponsor; StudyProtocolVersion.responsiblePartyCode
mapping:
  identity:
    v: rim
  map:
    v: .participation[typeCode=PRF].role[scoper.determinerCode=INSTANCE]

id:
  v: ResearchStudy.principalInvestigator
path:
  v: ResearchStudy.principalInvestigator
short:
  v: Researcher who oversees multiple aspects of the study
definition:
  v: A researcher in a study who oversees multiple aspects of the study, such as concept development, protocol writing, protocol submission for IRB approval, participant recruitment, informed consent, data collection, analysis, interpretation and presentation.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: ResearchStudy.principalInvestigator
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: Reference
  target profile:
    v: http://hl7.org/fhir/StructureDefinition/Practitioner
    link: http://hl7.org/fhir/StructureDefinition/Practitioner
  target profile:
    v: http://hl7.org/fhir/StructureDefinition/PractitionerRole
    link: http://hl7.org/fhir/StructureDefinition/PractitionerRole
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
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  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: clinicaltrials-gov
  map:
    v: Principal Investigator
mapping:
  identity:
    v: w5
  map:
    v: FiveWs.actor
mapping:
  identity:
    v: BRIDG5.1
  map:
    v: StudyInvestigator

id:
  v: ResearchStudy.site
path:
  v: ResearchStudy.site
short:
  v: Facility where study activities are conducted
definition:
  v: A facility in which study activities are conducted.
min:
  v: 0
max:
  v: *
base:
  path:
    v: ResearchStudy.site
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Reference
  target profile:
    v: http://hl7.org/fhir/StructureDefinition/Location
    link: http://hl7.org/fhir/StructureDefinition/Location
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: clinicaltrials-gov
  map:
    v: Facility
mapping:
  identity:
    v: w5
  map:
    v: FiveWs.where[x]
mapping:
  identity:
    v: BRIDG5.1
  map:
    v: PlannedStudySite; StudySite

id:
  v: ResearchStudy.reasonStopped
path:
  v: ResearchStudy.reasonStopped
short:
  v: accrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress | temporarily-closed-per-study-design
definition:
  v: A description and/or code explaining the premature termination of the study.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: ResearchStudy.reasonStopped
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: CodeableConcept
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
is modifier:
  v: false
is summary:
  v: true
binding:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName
    value: string
      v: ResearchStudyReasonStopped
  strength:
    v: example
  description:
    v: Codes for why the study ended prematurely.
  value set:
    v: http://hl7.org/fhir/ValueSet/research-study-reason-stopped
    link: http://hl7.org/fhir/ValueSet/research-study-reason-stopped
mapping:
  identity:
    v: clinicaltrials-gov
  map:
    v: Why Study Stopped
mapping:
  identity:
    v: w5
  map:
    v: FiveWs.why[x]
mapping:
  identity:
    v: BRIDG5.1
  map:
    v: StudyOverallStatus.studyStoppedReasonCode

id:
  v: ResearchStudy.note
path:
  v: ResearchStudy.note
short:
  v: Comments made about the study
definition:
  v: Comments made about the study by the performer, subject or other participants.
min:
  v: 0
max:
  v: *
base:
  path:
    v: ResearchStudy.note
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Annotation
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: BRIDG5.1
  map:
    v: No BRIDG mapping
mapping:
  identity:
    v: rim
  map:
    v: .inboundRelationship(typeCode=SUBJ].source[classCode=ANNGEN, moodCode=EVN].value[xsi:type=ST]

id:
  v: ResearchStudy.arm
path:
  v: ResearchStudy.arm
short:
  v: Defined path through the study for a subject
definition:
  v: Describes an expected sequence of events for one of the participants of a study. E.g. Exposure to drug A, wash-out, exposure to drug B, wash-out, follow-up.
min:
  v: 0
max:
  v: *
base:
  path:
    v: ResearchStudy.arm
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: BackboneElement
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: clinicaltrials-gov
  map:
    v: Arms
mapping:
  identity:
    v: BRIDG5.1
  map:
    v: Arm

id:
  v: ResearchStudy.arm.id
path:
  v: ResearchStudy.arm.id
representation:
  v: xmlAttr
short:
  v: Unique id for inter-element referencing
definition:
  v: Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Element.id
  min:
    v: 0
  max:
    v: 1
type:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type
    value: url
      v: string
  code:
    v: http://hl7.org/fhirpath/System.String
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: ResearchStudy.arm.extension
path:
  v: ResearchStudy.arm.extension
short:
  v: Additional content defined by implementations
definition:
  v: May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
alias:
  v: extensions
alias:
  v: user content
min:
  v: 0
max:
  v: *
base:
  path:
    v: Element.extension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  xpath:
    v: exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    link: http://hl7.org/fhir/StructureDefinition/Extension
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: ResearchStudy.arm.modifierExtension
path:
  v: ResearchStudy.arm.modifierExtension
short:
  v: Extensions that cannot be ignored even if unrecognized
definition:
  v: May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
requirements:
  v: Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension).
alias:
  v: extensions
alias:
  v: user content
alias:
  v: modifiers
min:
  v: 0
max:
  v: *
base:
  path:
    v: BackboneElement.modifierExtension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  xpath:
    v: exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    link: http://hl7.org/fhir/StructureDefinition/Extension
is modifier:
  v: true
is modifier reason:
  v: Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
is summary:
  v: true
mapping:
  identity:
    v: rim
  map:
    v: N/A

id:
  v: ResearchStudy.arm.name
path:
  v: ResearchStudy.arm.name
short:
  v: Label for study arm
definition:
  v: Unique, human-readable label for this arm of the study.
min:
  v: 1
max:
  v: 1
base:
  path:
    v: ResearchStudy.arm.name
  min:
    v: 1
  max:
    v: 1
type:
  code:
    v: string
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: clinicaltrials-gov
  map:
    v: Arm Label
mapping:
  identity:
    v: BRIDG5.1
  map:
    v: Arm.name

id:
  v: ResearchStudy.arm.type
path:
  v: ResearchStudy.arm.type
short:
  v: Categorization of study arm
definition:
  v: Categorization of study arm, e.g. experimental, active comparator, placebo comparater.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: ResearchStudy.arm.type
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: CodeableConcept
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: clinicaltrials-gov
  map:
    v: Arm Type
mapping:
  identity:
    v: BRIDG5.1
  map:
    v: Arm.typeCode

id:
  v: ResearchStudy.arm.description
path:
  v: ResearchStudy.arm.description
short:
  v: Short explanation of study path
definition:
  v: A succinct description of the path through the study that would be followed by a subject adhering to this arm.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: ResearchStudy.arm.description
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: string
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: clinicaltrials-gov
  map:
    v: Arm Description
mapping:
  identity:
    v: BRIDG5.1
  map:
    v: Arm.description

id:
  v: ResearchStudy.objective
path:
  v: ResearchStudy.objective
short:
  v: A goal for the study
definition:
  v: A goal that the study is aiming to achieve in terms of a scientific question to be answered by the analysis of data collected during the study.
min:
  v: 0
max:
  v: *
base:
  path:
    v: ResearchStudy.objective
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: BackboneElement
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: BRIDG5.1
  map:
    v: StudyObjective

id:
  v: ResearchStudy.objective.id
path:
  v: ResearchStudy.objective.id
representation:
  v: xmlAttr
short:
  v: Unique id for inter-element referencing
definition:
  v: Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Element.id
  min:
    v: 0
  max:
    v: 1
type:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type
    value: url
      v: string
  code:
    v: http://hl7.org/fhirpath/System.String
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: ResearchStudy.objective.extension
path:
  v: ResearchStudy.objective.extension
short:
  v: Additional content defined by implementations
definition:
  v: May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
alias:
  v: extensions
alias:
  v: user content
min:
  v: 0
max:
  v: *
base:
  path:
    v: Element.extension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  xpath:
    v: exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    link: http://hl7.org/fhir/StructureDefinition/Extension
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: ResearchStudy.objective.modifierExtension
path:
  v: ResearchStudy.objective.modifierExtension
short:
  v: Extensions that cannot be ignored even if unrecognized
definition:
  v: May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
requirements:
  v: Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension).
alias:
  v: extensions
alias:
  v: user content
alias:
  v: modifiers
min:
  v: 0
max:
  v: *
base:
  path:
    v: BackboneElement.modifierExtension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  xpath:
    v: exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    link: http://hl7.org/fhir/StructureDefinition/Extension
is modifier:
  v: true
is modifier reason:
  v: Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
is summary:
  v: true
mapping:
  identity:
    v: rim
  map:
    v: N/A

id:
  v: ResearchStudy.objective.name
path:
  v: ResearchStudy.objective.name
short:
  v: Label for the objective
definition:
  v: Unique, human-readable label for this objective of the study.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: ResearchStudy.objective.name
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: string
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: BRIDG5.1
  map:
    v: No BRIDG mapping (BRIDG has a description, but not a name)

id:
  v: ResearchStudy.objective.type
path:
  v: ResearchStudy.objective.type
short:
  v: primary | secondary | exploratory
definition:
  v: The kind of study objective.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: ResearchStudy.objective.type
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: CodeableConcept
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
is modifier:
  v: false
is summary:
  v: false
binding:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName
    value: string
      v: ResearchStudyObjectiveType
  strength:
    v: preferred
  description:
    v: Codes for the kind of study objective.
  value set:
    v: http://hl7.org/fhir/ValueSet/research-study-objective-type
    link: http://hl7.org/fhir/ValueSet/research-study-objective-type
mapping:
  identity:
    v: BRIDG5.1
  map:
    v: StudyObjective.typeCode

element:
  id:
    v: ResearchStudy
  path:
    v: ResearchStudy
  mapping:
    identity:
      v: fhir-osiris-study
    map:
      v: Study
    comment:
      v: Mapping from FHIR-osiris Study to osiris Study
element:
  id:
    v: ResearchStudy.identifier
  path:
    v: ResearchStudy.identifier
  short:
    v: EudraCT number of the clinical trial
  definition:
    v: The number in the EudraCT clinical trials database.
  min:
    v: 1
  max:
    v: 1
  mapping:
    identity:
      v: fhir-osiris-study
    map:
      v: OSIRIS_pivot_Treatment.Treatment_ClinicalTrialId
element:
  id:
    v: ResearchStudy.title
  path:
    v: ResearchStudy.title
  short:
    v: Clinical trial name
  definition:
    v: If the treatment is part of a clinical trial, its name is indicated.
  min:
    v: 1
  must support:
    v: true
  mapping:
    identity:
      v: fhir-osiris-study
    map:
      v: OSIRIS_pivot_Treatment.Treatment_ClinicalTrialName